The following data is part of a premarket notification filed by Hospital Products Co. with the FDA for Micro Z Blood Collecting Needles.
Device ID | K823696 |
510k Number | K823696 |
Device Name: | MICRO Z BLOOD COLLECTING NEEDLES |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | HOSPITAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-08 |
Decision Date | 1983-01-26 |